AB0311 ANALYSIS OF THE MALIGNANCY-RELATED SAFETY OF ABATACEPT FOR RHEUMATOID ARTHRITIS IN CLINICAL PRACTICE
Authors: Y. Kunishita, K. Harita, C. Honda, Y. Uzawa, M. Mitsuhashi, S. Ohta, T. Igarashi, S. Nagaoka
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> In 2019, a study based on post-marketing surveillance data in Japan reported that ABT was as effective and safe in elderly patients with rheumatoid arthritis (RA) as non-elderly<sup>[1]</sup>. However, there were inconsistent reports on the impact of ABT on malignancies which are more common in the elderly and strongly related to prognosis<sup>[2-4]</sup>, and there are still unanswered questions. <h3>Objectives</h3> To evaluate the incidence of malignancy and the efficacy and safety of previous malignancy in RA patients using ABT in our clinical practice. In addition, to explore the predictive risk factors of developing or relapsing malignancy during ABT use. <h3>Methods</h3> Patients who received ABT for RA at our department from October 2010 to May 2022 were included in the study. Patient background, prior malignancy at starting ABT, disease activity from starting ABT up to 60 months, continuation rates of ABT, and safety, including onset or recurrence of malignancy during ABT use, were retrospectively collected from electronic medical records. The patients were divided into two groups according to the absence or presence of previous malignancy (No previous malignancy: NP group, previous malignancy: PM group), and the collected parameters were compared between the groups. <h3>Results</h3> A total of 276 patients were included, of which 61 had previous malignancies when starting ABT. The age of starting ABT was significantly higher in the PM group (72.5 ± 10.6 vs. 68.5 ± 13.0years-old, <i>p</i> = 0.025), and the rate of methotrexate use was significantly lower in the PM group (29.5 vs. 51.2%, <i>p</i> = 0.0028), although there were no significant differences in other patient backgrounds between the groups (Table 1). The disease activity improved significantly at three months after starting ABT in both groups, and DAS28-CRP remission was maintained after that. There was no significant difference in disease activity between the groups from starting ABT to 60 months after. There were no significant differences in the continuation rates for 1-year and 5-year of ABT between the groups (86.3 vs. 86.6%, and 70.5 vs. 65.7%, respectively, Figure 1). There were 14 cases of occurrence and recurrence or progression of malignancy during the observation period. The incidence of malignancy was 1324.6 per 100,000 person-years, and there were no differences in the risk of malignancy in a Japanese national survey of similar age. Despite the significantly older patient population in the PM group, the 5-years incidence rate of malignancy was no significant difference between the groups. Binomial logistic analysis was performed using factors such as age, disease duration, history of previous malignancy, concomitant disease and medications, and disease activity at starting ABT. However, no predictive risk factors were found to be associated with the development or relapse of malignancy during ABT use in this study. <h3>Conclusion</h3> In our clinical practice, ABT was effective and safe in both patients with and without previous malignancy. <h3>References</h3> [1] Mod Rheumatol 2019 Sep; 29(5): 747-755. [2] Rheumatology 2019; 58: 683–91. [3] Arthritis Res Ther 2019; 21: 228. [4] Rheumatology 2020; 59: 2360–7. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Yosuke Kunishita Speakers bureau: AbbVie, Asahi Kasei Pharma, Astellas Pharma, AstraZeneca, Ayumi Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, Kyowa Kirin, Sanofi, UCB, Paid instructor for: AbbVie, Asahi Kasei Pharma, Astellas Pharma, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Eisai, Gilead Sciences, Kyowa Kirin, UCB, Kayo Harita: None declared, Chikara Honda: None declared, Yuji Uzawa: None declared, Masaki Mitsuhashi: None declared, Soichi Ohta: None declared, Toshihisa Igarashi: None declared, Shouhei Nagaoka: None declared.